Betacal

Package Leaflet: Information for the User

Betacal, (50 micrograms + 0.5 mg)/g
Calcipotriol+ Betamethasone

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you; do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Betacal and what is it used for
• 2. Important information before using Betacal
• 3. How to use Betacal
• 4. Possible side effects
• 5. How to store Betacal
• 6. Contents of the pack and other information

1. What is Betacal and what is it used for

Betacal contains the active substances calcipotriol and betamethasone. Calcipotriol helps to restore the normal rate of skin cell growth, and betamethasone has an anti-inflammatory effect.
Betacal is used for the local treatment of scalp psoriasis in adult patients and mild to moderate plaque psoriasis (psoriasis vulgaris) in adult patients, located on the body skin other than the scalp.
Psoriasis is caused by an excessive growth of skin cells, leading to redness, scaling, and thickening of the skin.

2. Important information before using Betacal

When not to use Betacal

• if you are allergic to calcipotriol, betamethasone, or any of the other ingredients of this medicine (listed in section 6),
• if you have disorders of calcium levels in the blood (consult your doctor),
• if you have other types of psoriasis, such as erythrodermic psoriasis, pustular psoriasis, or guttate psoriasis (consult your doctor).

Betacal contains a strong steroid, so you MUST NOT use this medicine for skin problems such as:
skin infections caused by viruses (e.g., herpes or chickenpox),
skin infections caused by fungi (e.g., athlete's foot or fungal infections caused by dermatophytes),
bacterial skin infections,
skin infections caused by parasites (e.g., scabies),
tuberculosis,
perioral dermatitis (red rash around the mouth),
thin skin, fragile blood vessels, stretch marks,
ichthyosis (dry skin with fish-like scales),
acne,
rosacea (severe flushing or redness of the face),
open sores or damaged skin.

Warnings and precautions

Before starting and during treatment with Betacal, discuss with your doctor or pharmacist if:
you are using other medicines containing corticosteroids, as side effects may occur,
you have been using this medicine for a long time and plan to stop using it (as there is a risk of worsening or "rebound" of psoriasis when steroids are stopped suddenly),
you have diabetes, as steroid medicines may affect blood sugar levels,
you have a skin infection, as treatment may need to be interrupted,
you have a certain type of psoriasis called guttate psoriasis,
you experience blurred vision or other vision disturbances.

Precautions

• Avoid using the medicine on more than 30% of the body surface and using more than 15 g per day.
• Avoid using the medicine under a bathing cap, bandages, or dressings, as this increases steroid absorption.
• Avoid using the medicine on large areas of damaged skin, mucous membranes, or skin folds (e.g., armpits, groin, under the breasts), as this increases steroid absorption.
• Avoid using the medicine on the face and genital areas, as they are more sensitive to steroids.
• Avoid excessive sunbathing, using sunbeds, or other forms of phototherapy.

Children and adolescents

Betacal is not recommended for use in children and adolescents under 18 years of age.

Betacal and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before using this medicine.
If your doctor agrees that you can breastfeed, be careful not to apply Betacal to the breast area.

Driving and using machines

This medicine should not affect your ability to drive or use machines.

Betacal contains butylhydroxytoluene (E 321)

Betacal contains butylhydroxytoluene (E 321), which may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

Betacal contains hydrogenated castor oil

Betacal contains hydrogenated castor oil, which may cause skin reactions.

3. How to use Betacal

Always use this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
How to apply Betacal:
Apply to the skin.
Instructions for proper use

• Use only on skin affected by psoriasis and avoid using on unaffected skin.
• Shake the tube before use and remove the cap.
• Squeeze the gel onto a clean finger or directly onto the affected skin area.
• Apply Betacal with your fingertips to the areas affected by psoriasis and gently spread until the affected skin is covered with a thinlayer of gel.
• Do not cover the treated areas with a bandage, tight dressing, or adhesive plaster.
• Wash your hands well after using Betacal to prevent accidental transfer of the gel to other parts of the body (especially the face, mouth, and eyes).
• Do not worry if some gel accidentally gets on healthy skin near the affected area, but wipe it off if it spreads too far.
• To achieve optimal effect, it is not recommended to take a shower or bath immediately after applying Betacal.
• After applying the gel, avoid contact with fabrics that may be stained by grease (e.g., silk).

If you have scalp psoriasis
Before applying Betacal to the scalp, comb your hair to remove any scales. Tilt your head to ensure the medicine does not run down your face. It may be helpful to part your hair. Apply Betacal with your fingertips to the affected area and gently massage.

It is not necessary to wash your hair before applying Betacal.

Shakethe tube before use
Apply directly
to the scalp
where the psoriasis plaque may
occur and rub the Betacal gel into the skin.
Depending on the area
affected by the disease, 1-4 g
(up to 1 teaspoon) of gel is usually
sufficient

To achieve optimal effect, it is not recommended to wash your hair immediately after using Betacal.

Betacal. Leave the medicine on the skin for the whole night or day. When washing your hair

Apply a small amount of Betacal
to the fingertip.
after application, the following instructions may be helpful:

Apply a mild shampoo to
dry hair,especially to
the areas where the gel was applied.
Leave the shampoo on the scalp
for a few minutes before rinsing.
Wash your hair as usual.

If necessary, repeat steps 4-6 once or twice.

Duration of treatment

• The gel should be used once a day. Using the gel in the evening may be more convenient.
• The usual initial treatment period is 4 weeks for scalp areas and 8 weeks for other skin areas.
• Your doctor may decide on a different treatment duration.
• Your doctor may decide to repeat the treatment.
• Do not use more than 15 grams of the medicine per day.

In case of using other medicines containing calcipotriol, the total amount of calcipotriol-containing medicines should not exceed 15 grams per day, and the treated skin area should not exceed 30% of the total body surface.
What results to expect when using Betacal
Most patients see noticeable treatment results after 2 weeks, even if the symptoms of psoriasis have not yet disappeared in the treated area.

Using more Betacal than recommended

If you use more than 15 g per day, contact your doctor.
Excessive use of Betacal may also cause disturbances in calcium levels in the blood, which usually disappear after treatment is stopped.
Your doctor may order blood tests to check if the use of more than the recommended amount of gel has caused disturbances in calcium levels in the blood.
Long-term, excessive use of Betacal may also cause disturbances in adrenal function (the adrenal glands are located near the kidneys and produce hormones).

Missing a dose of Betacal

Do not use a double dose to make up for a missed dose.

Stopping Betacal treatment

Stop using Betacal after consulting your doctor. It may be necessary to gradually stop using the medicine, especially if it has been used for a long time.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects
If you experience any of the following symptoms, tell your doctor or nurse immediately or as soon as possible. Treatment may need to be interrupted.
There have been reports of the following severe side effects of this medicine:
Uncommon side effects (may affect up to 1 in 100 people)

• Worsening of psoriasis. If your psoriasis worsens, tell your doctor as soon as possible.

It is known that some severe side effects are caused by betamethasone (a strong steroid), one of the ingredients of Betacal. Tell your doctor as soon as possible if you experience any of the following severe side effects. They are likely to occur after long-term use, use in skin folds (e.g., armpits, groin, under the breasts), use under occlusive dressings, or use on large areas of skin.
Side effects include:

• Adrenal glands may stop working properly. Symptoms are: tiredness, depression, and anxiety.
• Cataract (symptoms are: blurred or cloudy vision, difficulty seeing at night, and sensitivity to light) or increased pressure in the eye (symptoms are: eye pain, redness of the eye, decreased or blurred vision).
• Infections (due to suppression or weakening of the immune system fighting the infection).
• Pustular psoriasis (red area with yellowish pustules, usually on the hands or feet). If you notice such symptoms, stop using Betacal and contact your doctor as soon as possible.
• Effect on metabolic control of diabetes (in diabetes, fluctuations in blood sugar levels may occur).

Severe side effects caused by calcipotriol

• Allergic reactions with massive swelling of the face or other parts of the body, such as hands or feet. Swelling of the mouth or throat and difficulty breathing may occur. If an allergic reaction occurs, stop using Betacal and immediately inform your doctor or go to the emergency department of the nearest hospital.
• Treatment with this gel may cause an increase in calcium levels in the blood or urine (usually when too much gel is used). Signs of high calcium levels in the blood are: excessive urination, constipation, muscle weakness, confusion, and coma. This condition can be severe and you should contact your doctor immediately.However, after treatment is stopped, calcium levels usually return to normal.

Milder side effects
The following milder side effects of Betacal have been reported.
Common side effects (may affect up to 1 in 10 people)

• Itching.

Uncommon side effects (may affect up to 1 in 100 people)

• Irritation of the eyes.
• Burning sensation of the skin.
• Pain or irritation of the skin.
• Inflammation or swelling of the hair follicle (folliculitis).
• Rash with inflammation of the skin (dermatitis).
• Redness of the skin due to dilation of small blood vessels (erythema).
• Acne.
• Dryness of the skin.
• Rash.
• Pustular psoriasis.
• Skin infections.

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions.
• Stretch marks.
• Exfoliation of the skin.
• Rebound effect: worsening of psoriasis symptoms after treatment is stopped.

Frequency not known (frequency cannot be estimated from the available data)

• White or gray hair may temporarily turn yellowish at the application site, in case of use on the scalp.
• Blurred vision.

Milder side effects usually caused by betamethasone, especially with long-term use. Tell your doctor or nurse as soon as possible if you notice any of the following symptoms:

• Thinning of the skin.
• Appearance of superficial veins or stretch marks.
• Change in hair growth rate.
• Red rash around the mouth (perioral dermatitis).
• Skin rash with accompanying inflammation or swelling (allergic contact dermatitis).
• Yellowish, jelly-like bumps (colloid milia).
• Lightening of skin color (depigmentation).
• Inflammation or swelling of the hair follicle (folliculitis).

Other milder side effects known to be caused by calcipotriol included:

• Dryness of the skin.
• Sensitivity of the skin to light, resulting in a rash.
• Urticaria.
• Itching.
• Irritation of the skin.
• Burning or stinging sensation.
• Redness of the skin due to dilation of small blood vessels (erythema).
• Rash.
• Rash with inflammation of the skin (dermatitis).
• Worsening of psoriasis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Betacal

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the tube and carton after EXP. The expiry date refers to the last day of the month.
• Do not store in a refrigerator.
• Discard the tube with any remaining gel after 6 months of first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Betacal contains

The active substances of Betacal are calcipotriol and betamethasone.
One gram of gel contains 50 micrograms of calcipotriol (as calcipotriol monohydrate) and 0.5 mg of betamethasone (as betamethasone dipropionate).
The other ingredients are:

• liquid paraffin
• polyoxypropylene stearyl ether
• hydrogenated castor oil
• butylhydroxytoluene (E 321)

What Betacal looks like and contents of the pack

Betacal is a nearly transparent, colorless to slightly creamy gel packaged in a white HDPE tube with a white PP cap.
The tube is placed in a cardboard box.
Pack sizes:
1 tube of 30 g
1 tube of 60 g
Multipacks containing 60 g (2 tubes of 30 g) and 120 g (2 tubes of 60 g)
Not all pack sizes may be marketed.

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw

Manufacturer

Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany
Esparma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany
C.P.M Contract Pharma GmbH
Fruehlingstrasse 7
83620 Feldkirchen-Westerham
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Calcipotriol comp. Aristo 50 Mikrogramm/g + 0,5 mg/g Gel
Czech Republic
Talizon 50 Mikrogramů/g + 0,5 mg/g gel
Denmark
Calcipotriol/Betamethasone Aristo
Spain
CALCIPOTRIOL/BETAMETASONA ARISTO 50 MICROGRAMOS/G+0,5 MG/G GEL
Netherlands
Calcipotriol/Betamethason Aristo 50 microgram/g + 0,5 mg/g, gel
Ireland
Calcipotriol/Betamethasone 50 microgram/g + 0,5 mg/g gel
Germany
Calcipotriol comp. Aristo 50 Mikrogramm/g + 0,5 mg/g Gel
Norway
Calcipotriol/Betamethasone Aristo
Poland
BETACAL
Portugal
Katriomet 0,5 mg/g + 50 microgramas/g gel
Sweden
Calcipotriol/Betamethasone Aristo
United Kingdom
Calcipotriol/Betamethasone 50 micrograms / g + 0,5 mg / g, gel
(Northern Ireland)
Italy
Aribec
Date of last revision of the leaflet: January 2024